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cobas b 221 system
Blood gases,

Параметр Значение Ед. измерения
Основные параметры
Acceptable anticoagulants/Sampling technique EDTA, heparin, citrate/aspiration, injection, capillary transfer and fill, microsamples
Analytes measured on device pH, pCO2, pO2, Hct, Hb, Na, K, Cl, iCa, lactate, glucose, BUN, bilirubin, pH pleural fluid
Analytical method(s) or technologies employed pH: electrode ion-selective galvanometric; pCO2, pO2: electrode ion-selective membrane; Hct: conductivity; Hb: CO-ox spectrophotometry; Na, Cl, iCa, K: ion-selective potentiometry; lactate, glucose, BUN: MSS sensor enzyme
Analyzer connections cobas bge link, data-management systems, LIS or HIS
Average life expectancy of device 7 years
Barometric pressure recorded, measured
Built-in printer/Data port yes/RS-232, parallel, Ethernet
Calibration can be interrupted to perform stat sample yes
Calibration frequency 1 point: 30 minutes; two point: 8 hours
Calibrations required 1 and 2 point (automatic)
Categorized for point-of-care?testing or laboratory point-of-care?testing and laboratory
Contents downloaded from data management system to analyzer valid operator IDs
Cost per test/Reagent cost per test volume dependent/volume dependent
Device is part of a series of related models yes (3 models in series)
Device warranty/Loaner devices provided 1 year, parts and services/no
Dimensions (H x W x D)/Weight 23 ? 20 ? 23.6 inches/99 pounds (without solutions and AutoQC)
Disposable prepackaged system used for analysis reagent and electrode
Distinguishing features (provided by company) FDA 510(k)–cleared pH pleural fluid results; 42-day onboard reagent packs; Roche AutoQC with up to 40 days of QC covered; screen sharing and remote protected access with cobas bge link software and Axeda software
First year sold 2004
For what bar-code scanning is provided operator and patient IDs, reagent lot number, RF with transponders, expiration
Hardware and software for data management system cobas bge link software
How analyzer connects to external system to upload patient and QC results Ethernet
Information included in transmission from analyzer to external system device-unique identifier, operator and patient IDs, results, QC identifier
Information listed on hard copy report options can be customized; direct and measured parameters
Instrument response for calibration failure onscreen reporting with lockout capabilities
Instrument response for hardware failure/software failure identified onscreen and with diagnostic routine/onscreen with messages
Instrument response for QC failure onscreen report with high-low flagging, lockout capabilities
Interface standards supported ASTM, HL7, USB port
Internal QC program recommended CAP and JCAHO guidelines
Known interferences
Max. No. of analyte reagents that can reside in device at once 3
Maximum No. of patient samples per hour/Maximum No. measured results per hour 30/360
Method of analyst ID in system 32-level password system (customizable)
No. of different disposable reagents required to maintain device depends on model, contact Roche
No. of different management reports system produces 19 standard reports, plus customized reports; QC and patients results based on user validation rules; related patient RT inputs may be included; lid operator
No. of disposable reagent system units in standard package
No. of samples analyzed per one disposable reagent, electrode system
Number of devices sold in U.S./outside U.S./List price
Open or closed system/External gas tanks required closed/no
Optimal throughput when analyzer calibrated, awaiting specimens 30 patients samples per hour (full panel)
Parameters calculated on device Hb, Hct, O2SAT, BE, TCO2, HCO3-
Point of care:
Producer Roche Diagnostics
QC features/Capabilities of QC features L-J plots/comparable plot, lot-to-lot comparisons, statistical calculations, monthly cumulative reports, onboard, eQAP
Reagent unit storage requirements room temperature
Remote control of device from laboratory yes
Sample size differs with number of analytes selected yes, BG: 40 µL; ISE: 40 µL; CO-ox: 44 µL; glucose, lactate, BUN: 75 µL
Sample size for complete panel of analyte results 200 µL for full panel
Sampler has self-wiping probe yes
Service center performs diagnostics through modem yes
Shelf life of components reagent: 1 year; electrode: 18 months onboard
Shelf life of disposable units reagents: 12 months, electrodes: 18 months
Specimen types suitable for device plasma, serum, whole blood, capillary, arterial, venous
System can use LOINC to transmit results to LIS yes
System connected (live installations) to which LISs, HISs Cerner, Meditech, others
Time from sample introduction to result availability ~1 minute (test dependent)
Time required for maintenance by lab personnel daily: 2 minutes, monthly: 5 minutes, quarterly: 5 minutes
Use a third-party interfacing tool, engine for LIS, HIS interfaces Data Innovations

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